Invitrogen Corporation
Country not established
- Devices
- 2
What Invitrogen Corporation makes
Invitrogen Corporation manufactures cell culture media, such as the AIM-V Medium (Model 087-0112), designed for maintaining and growing specific cell lines in laboratory settings. The company also produces diagnostic kits, including the Spot-Light HER2 CISH Kit, used for detecting HER2 gene amplification in tissue samples via chromogenic in situ hybridization (CISH).
These products are regulated under FDA pathways, with the cell culture medium classified as Class II and the diagnostic kit as Class III. The AIM-V Medium is supported by a 510(k) clearance, while the HER2 CISH Kit requires a Premarket Approval (PMA). Invitrogen Corporation is headquartered in the United States.
Catalogue
Aim-V (R) Medium, Model 087-0112 Ref K022086
Regimes: 510(k) Registry: 510(k)Spot-Light HER2 Cish Kit Ref P050040
Regimes: PMA, withdrawn Registry: PMA
Frequently asked questions
How many devices does Invitrogen Corporation have in the registry?
The registry currently lists 2 devices for Invitrogen Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Invitrogen Corporation's devices?
Among its 2 most recently registered devices, Invitrogen Corporation has devices listed in FDA 510(k) (1 device) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Invitrogen Corporation's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Invitrogen Corporation's devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Invitrogen Corporation in the registry?
The most recently registered devices listed for Invitrogen Corporation include AIM-V (R) MEDIUM, MODEL 087-0112 and SPOT-LIGHT HER2 CISH KIT.